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# Drug/Biologic Accelerated Approval Draft Guide
- URL: https://www.fdaweb.com/drug-biologic-accelerated-approval-draft-guide/
- Published: 2024-12-06T12:00:00.000Z
- Updated: 2026-09-14T14:48:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158318

*Federal Register* notice: FDA is making available a draft guidance entitled “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics.” The document provides information on the agency’s policies and procedures for the accelerated approval program, including which products may be eligible, the standards for granting approval, and the procedures for withdrawing an product previously granted accelerated approval. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-12-06/pdf/2024-28392.pdf?ref=fdaweb.com).